Implementing Quality by Design in Pharmaceutical Salt Selection: A Modeling Approach to Understanding Disproportionation

@article{Merritt2012ImplementingQB,
  title={Implementing Quality by Design in Pharmaceutical Salt Selection: A Modeling Approach to Understanding Disproportionation},
  author={Jeremy M. Merritt and Shekhar K. Viswanath and Gregory A. Stephenson},
  journal={Pharmaceutical Research},
  year={2012},
  volume={30},
  pages={203-217}
}
Salts of active pharmaceutical ingredients are often used to enhance solubility, dissolution rate, or take advantage of other improved solid-state properties. The selected form must be maintained during processing and shelf-life to ensure quality. We aimed to develop a model to quantify risk of disproportionation, where the salt dissociates back to the freebase form. A mechanistic model based on thermodynamics was built to predict disproportionation. Stress testing of molecules in combination… CONTINUE READING
Recent Discussions
This paper has been referenced on Twitter 1 time over the past 90 days. VIEW TWEETS

Citations

Publications citing this paper.
Showing 1-9 of 9 extracted citations

References

Publications referenced by this paper.
Showing 1-10 of 27 references

Strategy for the prediction and selection of drug substance salt forms

  • HG Brittain
  • Pharm Technol
  • 2007

A study on moisture isotherms of formulations : the use of polynomial equations to predict the moisture isotherms of tablet products

  • Y Qiu, Y Chen, L Liu, G Zhang, Y Li, YD Sanzgiri
  • AAPS Pharm Sci Tech
  • 2003

Similar Papers

Loading similar papers…